Bioequivalence study of Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala in comparison with Zorvolex 35 capsule produced by Catalent CTS, LLC United States for Iroko Pharmaceuticals Inc., British Virgin Islands.

1. Background
Registration Number	INA-PGABK49
Date of registry approval	27-11-2023
Registration Date	24-11-2023
Secondary identifiers	No
Name of issuing authority (for example protocol number, other registries, etc)
Secondary identifier number
Scientific study title	Bioequivalence study of Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala in comparison with Zorvolex 35 capsule produced by Catalent CTS, LLC United States for Iroko Pharmaceuticals Inc., British Virgin Islands.
Public (popular study title)	Bioequivalence study of Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala in comparison with Zorvolex 35 capsule produced by Catalent CTS, LLC United States for Iroko Pharmaceuticals Inc., British Virgin Islands.

2. Sponsor and Funding
Primary Sponsor	PT Pratapa Nirmala
Source(s) of monetary or material support	PT Pratapa Nirmala
Other partners	PT Omega Medika Farma Laboratori

3. Contact details
Principal Investigator
Principal investigator	apt. Noviyanto, S.Farm
City	Jakarta
Country	Indonesia
Principal investigator's affiliation	PT Omega Medika Farma Laboratori
Principal Investigator's email address	admin@omegaresearch.id
Public Queries
Contact person name for public queries	apt. Noviyanto, S.Farm
Address for public queries	PT Omega Medika Farma Laboratori Jl. Kramat Raya No. 61A, Jakarta Pusat, 10450
City	Jakarta
Country	Indonesia
ZIP	10450
Affiliation for public queries	PT Omega Medika Farma Laboratori
Email address for public queries	admin@omegaresearch.id
Phone number for public queries	021- 3905831
Scientific Queries
Name of Contact for scientific queries	apt. Noviyanto, S.Farm
Address for scientific queries	PT Omega Medika Farma Laboratori Jl. Kramat Raya No. 61A, Jakarta Pusat, 10450
City	Jakarta
Country	Indonesia
ZIP	10450
Affiliation of scientific queries contact	PT Omega Medika Farma Laboratori
Email address for scientific queries	admin@omegaresearch.id

4. IRB & Regulatory
Ethical Approval number	KET-192/UN2.F1/ETIK/PPM.00.02/2021
Name of Ethics committee	Komite Etik Penelitian Kesehatan Fakulta Kedokteran Universitas Indonesia - RSUPN Dr. Cipto Mangunkusumo
Date of Ethic approval	08-03-2021
Contact details of Ethic Committee (phone, email, and office)	Gedung H Fakultas Kedokteran UI, Jalan Salemba Raya No. 6 Jakarta 10430, Po. Box 1358, Telp: 021 – 3157008 Website: komite-etik.fk.ui.ac.id
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	RG.01.02.321.03.21.00063/UB

5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	Jakarta
Recruitment status	Complete
Date of first enrollment	10-04-2021
Targeted Sample size	00016 -
Number of enrolled participants	16
Date of study completion (last participant, last visit)	17-04-2021

6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	Healthy Subjects
Purpose of the study	Bioequivalence study
Study type	Interventional
Interventional Study category	Bioequivalence study
Method of allocation
Description of the allocation concealment mechanism and sequence generation
Masking
Study intervention (study arm)	The reference drug was the market available Zorvolex 35 capsule, batch number MF 1391; manufacturing date June 2019; expiration date June 2021 The test drug was Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala, batch number LK 1831; manufacturing date November 2020; expiration date November 2022. In the morning of the sampling as scheduled, subjects were given one dose of Diclofenac Acid products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position.
Control intervention (control arm)
Intervention assignment	Crossover

7. Eligibility Criteria
Gender inclusion criteria	Not specified
Minimum age	18
Maximum age	55
Inclusion criteria	Willing to sign the informed consent, Age 18 – 55 years, Body mass index between 18 – 25 kg/m2, Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60-80 mmHg), heart rate 60 – 90 beats per minute, Healthy male/female (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood sugar and urinalysis; history of disease, and physical examination),
Exclusion criteria	Contraindicated and/or has history of hypersensitivity to Diclofenac acid or related drug, With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease, Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day, Participated in any clinical study within 3 months prior the study, Donated or lost 300 mL (or more) of blood within 3 months prior the study, Smoke more than 10 sticks of cigarettes a day, Have any bleeding or coagulation disorder, Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV, With the history of alcohol and drug abuse, pregnant or lactating women, female subjects who give positive pregnancy test at pre-study examination, If the study is conducted in Covid-19 pandemic situation, the exclusions criteria below must be applied: a. With history of travelling to another city within last 14 days, b. With history of direct contact with a Covid-19 positive person in the subject neighborhood, b. With history or present sore throat, fever (temperature more than 37oC) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test.

8. Study Outcome
Primary Outcome
Name of primary outcome	AUCt and Cmax
Metric/method of measurement	Diclofenac concentration in plasma with LC/MS
Timepoint(s) of measurement	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, and 12 hours
Secondary outcome 1
Name of secondary outcome 1 (SO1)	AUCinf, tmax, half-life
Metric/method of measurement (SO1)	Diclofenac concentration in plasma with LC/MS
Timepoint(s) of measurement (SO1)	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, and 12 hours

9. Study Results
Brief summary of study results	From the result of study it was concluded that Diclofenac acid 35 mg capsule batch number LK 1831 produced by PT. Pratapa Nirmala was bioequivalent to its reference, Zorvolex 35 capsule, batch number MF 1391 produced Catalent CTS, LLC United States for Iroko Pharmaceuticals Inc., British Virgin Island.
Date of results summaries	30-04-2021
Participant flow
Baseline characteristic
Adverse events
Outcome measures

10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	No
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations